What this study is
Chronic Traumatic Brain Injury (cTBI) symptoms exist in individuals who experienced previous traumatic brain injuries. There are 80-90 thousand individuals who are clinically diagnosed with cTBI, with estimated costs at greater than 60 billion dollars. However, there is a lack of studies using comprehensive diagnostic imaging tools to better understand physiological ramifications of the injury that may help guide therapy. This study uses integrative medicine approaches for persons with cTBI. Another aim of this study will be a continuation of this protocol in an effort to address the ongoing distressing physiological and psychological (anxiety and depression) symptoms associated with cTBI. After completion of the initial 3 study arms, the investigators have amended the protocol to evaluate the physiological and psychological effects and potential symptom improvement of integrative medicine approaches in cTBI patients using the Neuro Emotive Technique (NET). Participants may be re-enrolled in the NET group after completion of participation in the initial study arms. The participants in the NET substudy will be interviewed about Subjective Units of Distress (SUDS) associated with the cTBI event initially and after completion of the NET sessions.
What's being tested
- Anti-inflammatory Diet
Intervention · OTHER
Integrative diet that reduces saturated fats and carbohydrates and emphasizes proteins and omega-3 fats that help reduce inflammation and oxidative damage.
- N-acetyl Cysteine
Intervention · DIETARY SUPPLEMENT
Intravenous and Oral n-acetyl cysteine
- Neuro Emotive Technique
Intervention · BEHAVIORAL
Neuro Emotive Technique sessions
Study details
- Official title
- Defining Neurobiological Signatures for Chronic Traumatic Brain Injury Using PET-MRI Technology
- Sponsor
- Thomas Jefferson University
- Conditions
- Chronic Traumatic Brain Injury
- Enrolling
- 150 people
- Starts
- 2017-06-07
- Est. completion
- 2027-07-08
- Design
- Open-label, non-randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Individuals with a history of TBI and complaints of persistent symptoms including cognitive impairment, emotional disturbances, headache, or other symptoms associated with TBI
- Age 18-80 years old
- Patients had no other pre-existing history (i.e. prior to the TBI) of significant medical, neurological, or psychological disorders such as schizophrenia or active substance abuse.
- Minor, stable health problems that should have no substantial effect on cerebral blood flow will be allowed (i.e. controlled hypertension, medication controlled diabetes)
- Able to give informed consent and willing to complete the study
- Patients will be allowed to be taking medications or supplements at the initial intake, but they must be on a stable dose regimen for at least 1 month
- Women of childbearing potential will confirm a negative pregnancy test NET Substudy: Anxiety and/or distress associated with TBI or TBI symptoms by measurement with Subjective Units of Distress, and biofeedback screening
You can't join if
- Previous brain surgery.
- Cognitive impairment with significant impact on activities of daily living and/or a score on the Mini-Mental Status examination (or similar) of 25 or lower
- Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area).
- Pregnant or lactating women.
- Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
- Any pre-existing medical conditions that may interfere with cerebral function.
- Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight > 350 pounds)
- Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging. Additional exclusionary criteria for the NAC arm:; Patients taking medications that might interact with the NAC involved in this study will be evaluated on a case by case basis by the PI or study physician.; Patients that have a history of uncontrolled conditions, e.g.: diabetes, asthma, gastroesophageal reflex disease, or thyroid conditions
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openThomas Jefferson University, Marcus Institute of Integrative Health Centers
Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Villanova, Pennsylvania, United States
Study team
Sponsor
Thomas Jefferson University
Study ID 17D.138
Principal investigator
Andrew B. Newberg, MD
Thomas Jefferson University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.